C3 Laminectomy With Cervical Laminoplasty

Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.
2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty.

Study Overview

• Status: Withdrawn
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: laminectomy at C3 level

Detailed Description

Surgery is performed under general anesthesia as before, followed by posterior cervical incision. In one group, the cervical spine of the C3 is removed using a drill and punch and C4-6 laminoplasty will be performed. In the other group, C3-6 laminoiplasty will be performed. Postoperative suturing and subject management are the same as existing patient care policies. Follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. The degree of the neck pain is measured using NDI and VAS for each outpatient f/u.

• Study Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with cervical stenosis who should undergo cervical laminoplasty

Description

Inclusion Criteria:

• cervical stenosis

Exclusion Criteria:

• metastatic tumor
• fracture
• previous cervical spine surgery (posterior approach)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
C3 laminectomy; laminectomy at C3 level and laminoplasty at C4-6 level	Procedure: laminectomy at C3 level; laminectomy at C3 level
C3 laminoplasty; laminoplasty at C3-6 level	Procedure: laminectomy at C3 level; laminectomy at C3 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neck pain	Numerical rating pain score on neck, 0~10, 0 is no pain, 10 is maximum pain	1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chun Kee Chung, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Estimated): December 31, 2021
• Study Completion (Estimated): December 31, 2021

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: C3 ectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No